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Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (CARMEN-LC06)

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ClinicalTrials.gov Identifier: NCT05245071
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).

Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.


Condition or disease Intervention/treatment Phase
Non-squamous Non-small Cell Lung Cancer Drug: Tusamitamab ravtansine Phase 2

Detailed Description:
40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Actual Study Start Date : June 3, 2022
Estimated Primary Completion Date : February 2, 2024
Estimated Study Completion Date : May 24, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tusamitamab ravtansine
Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Drug: Tusamitamab ravtansine
Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion
Other Name: SAR408701




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
    Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities [ Time Frame: Baseline up to approximately 90 days after the last study treatment administration ]
    Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. Progression-free survival (PFS) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
    PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.

  3. Disease control rate (DCR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
    DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1

  4. Duration of response (DOR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
    DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first

  5. Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine [ Time Frame: Baseline up to approximately 30 days after the last study treatment administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
  • Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
  • At least one measurable lesion by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.

Exclusion Criteria:

  • Patients with untreated brain metastases or history of leptomeningeal disease.
  • History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
  • History of known uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
  • Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
  • Nonresolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
  • Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
  • Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
  • Concurrent treatment with any other anticancer therapy
  • Poor bone marrow, liver or kidney functions.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05245071


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT05245071    
Other Study ID Numbers: ACT17241
U1111-1264-2828 ( Registry Identifier: ICTRP )
2021-004423-32 ( EudraCT Number )
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 10, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Maytansine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action